Hazardous material handling system and method

ABSTRACT

A method and system for handling hazardous materials contained in a vial includes an isolation enclosure having an opening selectively sealable about the vial, a bag body portion, and a cap portion. A latching extraction element is attached to the cap portion and has a preceding engaging member to secure the vial to the isolation enclosure, an extraction member to be inserted into the vial and remove material therefrom, and a primary engaging member to secure the vial to the extraction member. A valve is mounted outside the isolation enclosure and controls the flow of fluid from the vial. An adaptor having a reseal member permits flow when coupled to the valve and restricts flow when uncoupled from the valve. Once uncoupled, the adaptor is removably associated with a second valve located remotely from the isolation enclosure, allowing fluid to pass into the second valve.

BACKGROUND OF THE INVENTION

[0001] The present invention relates to the field of handling hazardousmaterials, including but not limited to materials such as drugs used formedical purposes. More particularly, this invention relates to a meansand method for enabling a user to transfer a hazardous material from asealed vial or container without allowing significant leakage of thematerial to the environment. Specific examples of hazardous materials towhich the invention is particularly applicable include but are notlimited to liquid, freeze dried or powdered cytotoxic drugs that areused extensively in chemotherapy treatment of cancer patients andradiographic materials.

[0002] High toxicity materials, including cytotoxic drugs andradiographic materials, are often enclosed in small bottles or vialsthat have an opening sealed by an elastomeric plug. It is highlydesirable to prevent spillage or escape of even minimal amounts ofhazardous materials in either liquid or gas form. Small droplets ofmaterials could undesirably contaminate the ambient environment or comein contact with the person administering the substance.

[0003] Hazardous drugs are compounded in different ways. In largehospital pharmacies and homecare pharmacies, pharmacy technicianswearing gowns and double gloves compound hazardous drugs under ventedbiological laboratory hoods. These specially designed hoods areexpensive and take up valuable floor space. In hospital wards, clinics,doctors' offices and other locations, laboratory hoods may not bereadily available and the personnel compounding the drugs may notusually wear such elaborate protective equipment. Shelf life limitationsand patient specific dosing requirements may demand that the drug bemixed closer in time and space to the point of care.

[0004] According to one conventional means and method used at the pointof care, the user utilizes a sharp needle attached to a syringe topierce an elastomeric plug or other cap that seals the vial and draw thedrug out, often after injecting a suitable solvent or diluents into thevial. The user then injects the drug into a reseal element on anintravenous (IV) container from which the drug is delivered to thepatient. Unfortunately, this method creates another hazard in that theperson handling the drug or someone else can be “pricked” by the sharpneedle.

[0005] Therefore, a principal object of this invention is to provide amethod and means for securing a vial within an impermeable isolationenclosure.

[0006] A further object of the invention is to provide a method andmeans for piercing a vial within the impermeable isolation enclosure ina fixed position; and selectively accessing the contents of the vial.

[0007] Another object of the invention is to provide a method and meansfor safely transferring a portion of the vial contents, while the vialremains pierced within an impermeable isolation enclosure.

[0008] These and other objects will be apparent to those skilled in theart.

SUMMARY OF THE INVENTION

[0009] A method and system for handling hazardous materials contained ina vial includes an isolation enclosure having an opening selectivelysealable about the vial, a bag body portion, and a cap portion. Alatching extraction element is attached to the cap portion and has apreceding engaging member to secure the vial to the isolation enclosure,an extraction member adapted to be inserted into the vial and removematerial therefrom, and a primary engaging member to secure the vial tothe extraction member. A valve mounted outside the isolation enclosurecontrols the flow of fluid from the vial. An adaptor having a resealmember permits flow when coupled to the valve and restricts flow whenuncoupled from the valve. Once uncoupled, the adaptor is removablyassociated with a second valve located remotely from the isolationenclosure, allowing fluid to pass into the second valve.

DESCRIPTION OF THE DRAWINGS

[0010]FIG. 1 is a top view of the material handling system of thisinvention;

[0011]FIG. 2 is a partial sectional side view of the material handlingsystem of this invention taken on line A-A of FIG. 1;

[0012]FIG. 3 is a partial sectional side view similar to FIG. 2 of analternative embodiment of the material handling system of thisinvention;

[0013]FIG. 4 is a bottom view of a latching extraction element of thepresent invention;

[0014]FIG. 5 is a side view of the latching extraction element of thepresent invention;

[0015]FIG. 6 is a sectional side view of the latching extraction elementof the present invention taken on line B-B of FIG. 4;

[0016]FIGS. 7, 8 and 9 are sequential sectional side views of thelatching extraction element of the present invention associating with avial taken on line A-A of FIG. 4;

[0017]FIG. 10 is a rear view of an adaptor of the present invention;

[0018]FIG. 11 is a sectional side view of the adaptor of the presentinvention; and

[0019]FIGS. 12 and 13 are sequential sectional side views of the adaptorattached to a syringe and associating with a valve.

DESCRIPTION OF THE PREFERRED EMBODIMENT

[0020] With reference to FIG. 2, a material handling system 10 for usewith a sealed vial 12 includes an isolation enclosure 14 adapted tocompletely enclose the vial 12. It will be understood by those skilledin the art, that the term vial, as used herein, includes but is notlimited to any type of sealed container, ampule, or bottle. A sealingclosure 13 is attached to or integrally formed with the vial 12. In thecase of a bottle, an elastomeric stopper can seal the opening of thecontainer.

[0021] The isolation enclosure 14 is impermeable and has a body portion16, a cap portion 17, and an opening 20 that is selectively sealable bya closure portion 22. In one embodiment, the body portion 16 is aflexible bag constructed of a material that is transparent ortranslucent. The cap portion 17 is constructed of a rigid material andhas an inlet port 18 and an outlet port 19. Of course, one of ordinaryskill in the art will recognize that the body portion 16 can besemi-rigid or rigid and the cap portion 17 can be semi-rigid or evenflexible in whole or part without detracting from the present invention.

[0022] Opening 20 is optionally located in any convenient location onthe isolation enclosure 14. In one embodiment, the opening 20 is formedbetween the body portion 16 and the cap portion 17. The closure portion22 includes a fastener 24 located on the body portion 16 and a fitting26 located on the cap portion 17. The fastener 24 and fitting 26 mate toselectively seal the opening 20 and form the closure portion 22. It willbe understood by one of ordinary skill in the art that the closureportion 22 may be of any known design, including but not limited tosnaps fittings, threaded fittings, latch fittings, hook fittings, andclamp fittings.

[0023] With reference to FIG. 3, the opening 20 is formed in the bodyportion 16 in another embodiment. The closure portion 22 includes amated track 28 located on the body portion 16 about the opening 20 and azipper element 30 located on body portion 16 and about the mated track28. The zipper element 30 is slidably associated with the mated track 28to selectively close the opening 20. It will be understood by one ofordinary skill in the art that the closure portion 22 may be of anyknown design, including but not limited to clips, clamps, zipper freemated track seals, and adhesive.

[0024] A latching extraction element 32 is attached to the cap portion17 and has a preceding engaging member 34 to secure the vial 12 to thematerial handling system 10, an extraction member 36 to extend into andremove material from the vial 12, and a primary engaging member 38 tosecure the vial 12 to the extraction member 36.

[0025] With reference to FIG. 4, the preceding engaging member 34 ismounted on a body portion 40. The preceding engaging member 34 has aplurality of latch arms 42 positioned, preferably equally spacedperipherally, around the body portion 40 and extending from the bodyportion 40 in the same direction as the extraction member 36. Withreference to FIG. 8, the latch arms 42 are positioned and adapted tosecure the vial 12 to the extraction member 36 in a first or precedingfixed position wherein the extraction member 36 is outside the vial 13.Once the vial 12 is secured, the opening 20 is closed to seal theisolation enclosure 14.

[0026] With reference to FIG. 7, the extraction member 36 is located ata proximal end of the body portion 40 and has an elongated fluid passage44 extending through both the extraction member 36 and the body portion40. With reference to FIG. 9, the extraction member 36 is adapted to beinserted into the vial 12 (preferably by puncturing the closure 13) andto remove material from the vial 12 through the fluid channel 44. Theextraction member 36 can be of any known design other than a needle,including but not limited to a spike or piercing pin, a blunt cannula,and a tube. For example, a spiking pin is illustrated in the figures.

[0027] With reference to FIG. 6, a vent channel 46 extends through boththe extraction member 36 and the body portion 40, to a vent port 48. Thevent channel 46 allows gas in the vial 12 to escape via the vent port 48when fluid is inserted into the vial 12 by the fluid channel 44.

[0028] With reference to FIGS. 4 and 5, the primary engaging member 38has a plurality of latch arms 50 positioned, preferably equally spacedperipherally, around the body portion 40 and extending from the bodyportion 40 in the same direction as the extraction member 36. The latcharms 50 are preferably positioned in staggered relation to the latcharms 42 of the preceding engaging member 34 around the body portion 40.With reference to FIG. 9, the latch arms 50 are positioned and adaptedto secure the vial 12 in a second latched or primary fixed position withthe extraction member 36 extending thereinto. The extraction member 36extends a greater distance from the body portion 40 than the latch arms50, but less than the latch arms 42.

[0029] With reference to FIG. 2, a connecting member 52 is located at adistal end of the body portion 40. The connecting member 52 is in fluidcommunication with the fluid passage 44 and is capable of attaching thelatching extraction element 32 to the inlet port 18 of the cap portion17.

[0030] International Publication Number WO 94/08549 describes oneembodiment of a latching extraction element or piercing pin suitable forthe present invention; said description is expressly incorporated hereinin its entirety.

[0031] As best seen in FIGS. 2 and 3, a valve 54 is mounted to theoutlet port 19 of the cap portion 17, outside the isolation enclosure14. The valve 54 is in fluid communication with the fluid passage 44 andcontrols the flow of fluid to and from the vial 12.

[0032] With reference to FIGS. 2, 3, 12 and 13, the valve 54 has athreaded outer surface 56, a hollow spiked pin 58 connected in fluidflow communication with the fluid passage 44, and a seal member 60positioned about the hollow spiked pin 58 to selectively restrict flowthrough the hollow spiked pin 58.

[0033] U.S. Pat. No. 5,738,663 describes one embodiment of a valvesuitable for the present invention; said description is expresslyincorporated herein in its entirety. The valve described in U.S. Pat.No. 5,738,663 is commonly known as a CLAVE® valve and is commerciallyavailable from ICU Medical Inc. of San Clemente, Calif., U.S.A.

[0034] With reference to FIGS. 10-13, an adaptor 62 permits flow throughvalve 54 when coupled to the valve 54 and restricts flow when uncoupledfrom the valve 54. The adaptor 62 has a body 64 with an elongated fluidpassage 66 therethrough. A fastening element 68, which includes raisedgrips, threads, or lugs 69 thereon, is located at a proximal end of thebody 64 for releasably coupling the adaptor 62 to the valve 54 anddrawing them together in an axial direction. Such a coupling is commonlycalled a luer-lock connection.

[0035] An actuating post 70 is located at the proximal end of the body64 and along the fluid passage 66. The actuating post 70 extends beyondthe fastening element 68 in the proximal direction. The actuating post70 is adapted to penetrate the valve 54, compress the seal member 60,and expose the hollow spiked pin 58, thus opening the valve 54.

[0036] The adaptor 62 has a reseal member 72 coupled to the actuatingpost 70 and in fluid communication with the fluid passage 66. The resealmember 72 is preferably formed of a resilient elastomeric material andhas a preslit opening 74 that is normally closed due to the resiliencyof the reseal member 72. The preslit opening 74 is adapted to receivethe hollow spiked pin 58, opening the adaptor 62 to fluid flow from thevalve 54. The preslit opening 74 closes when uncoupled from the valve54, thus restricting flow out of the fluid passage 66.

[0037] A port 76 is located at a distal end of the body 64 and along thefluid passage 66. The port 76 is adapted to fluidly connect the adaptor62 to a needleless syringe 78. Raised grips, threads, or lugs 80 areprovided on the body 64 for facilitating connecting the adaptor 62 tothe needleless syringe 78. It will be understood to one skilled in theart, that the adaptor 62 and needleless syringe 78 could be made of aunitary construction.

[0038] With reference to FIGS. 2, 8, 9, 12 and 13, in operation the vial12 is placed within the open isolation enclosure 14. The vial 12 issecured to the material handling system 10 in a first preceding latchedor fixed position by forcing the vial 12 to engage the precedingengaging member 34. Once the vial 12 is secured, the isolation enclosure14 is closed.

[0039] Alternatively, the latching extraction element 32 is providedseparate from the isolation enclosure 14. In this case, the vial 12 isfirst secured to the preceding engaging member 34 outside the isolationenclosure 14. Once the latching extraction element 32 and vial 12 aresecured together, they are placed within the open isolation enclosure14. The connecting member 52 of the latching extraction element is thenattached to the inlet port 18 of the cap portion 17, securing the vial12 within the isolation enclosure 14. Once the vial 12 is secured, theisolation enclosure 14 is closed.

[0040] The vial 12 can then be safely punctured by gripping the vialthrough the flexible bag body portion 16 and forcing the vial 12 tosimultaneously engage the extraction member 36 and the primary engagingmember 38. The extraction member 36 thus punctures the vial 12 andpermits access to the vial 12. The primary engaging member 38 securesthe vial 12 to the extraction member 36.

[0041] Typically, a diluent will be added at this point to the vial 12.To accomplish this, a diluent containing needleless syringe 78 isequipped with the adaptor 62. The adaptor 62 is engaged to the valve 54,opening both the hollow spiked pin 58 and the preslit opening 74 tofluid flow. The diluent is added to the vial 12, and excess gas isvented from the vial through vent port 48.

[0042] Once diluted, a portion of the vial 12 contents is removed intothe syringe 78. The adaptor 62 and syringe 78 are disconnected from thevalve 54. When disconnected, the hollow spiked pin 58 and the preslitopening 74 are resealed, maintaining their respective contents inisolation. At this point the vial 12 remains pierced by the extractionmember 36 and fixed by the primary engaging member 38.

[0043] The contents of the syringe 78 are now transferred to a desireddestination. The transfer occurs by removably associating the adaptor 62and syringe 78 to a second valve 54 located remotely from the isolationenclosure 14. Again, both the hollow spiked pin 58 and the preslitopening 74 are opened allowing fluid to pass into the second valve 54.

[0044] It is therefore seen that the present invention provides a methodand means capable of securing a vial within an impermeable isolationenclosure. The present invention further provides a method and meanscapable of piercing a vial within the impermeable isolation enclosure ina fixed position; and selectively accessing the contents of the vial.The present invention also provides a method and means capable of safelytransferring a portion of the vial contents, while the vial remainspierced within an impermeable isolation enclosure.

[0045] It is therefore seen that this invention will accomplish at leastall of its stated objectives.

I claim:
 1. A material handling system for use with a sealed vial,comprising: an isolation enclosure adapted to completely enclose thevial; a latching extraction element mounted within the isolationenclosure and including an extraction member having a fluid channel, theextraction member being adapted to be inserted into the vial and toremove material from the vial through the fluid channel; and a primaryengaging member mounted within the isolation enclosure and adapted tosecure the vial to the latching extraction element in a fixed positionwherein the extraction member extends into the vial for removal ofmaterial therefrom.
 2. The apparatus of claim 1, wherein the isolationenclosure has an opening that is selectively sealable by a closureportion.
 3. The apparatus of claim 2, wherein the isolation enclosurehas a body portion and a cap portion.
 4. The apparatus of claim 3,wherein the closure portion comprises a fastener located on the bodyportion and a fitting located on the cap portion, wherein the fastenerand fitting mate to selectively seal the opening.
 5. The apparatus ofclaim 3, wherein the body portion is a flexible bag.
 6. The apparatus ofclaim 5, wherein the body portion is constructed of a materialpermitting an amount of light to pass through rendering the body portionat least translucent.
 7. The apparatus of claim 3, wherein the capportion is constructed of a rigid material, and is connected to thelatching extraction element.
 8. The apparatus of claim 1, furthercomprising a preceding engaging member mounted within the isolationenclosure and adapted to secure the vial in a preceding fixed positionadjacent to the extraction member such that the extraction member islocated outside the vial.
 9. The apparatus of claim 1, furthercomprising a valve mounted outside the isolation enclosure in fluid flowcontact with the fluid channel and adapted to control the flow of fluidfrom the vial.
 10. The apparatus of claim 9, further comprising anadaptor having a reseal member, capable of removably associating influid flow contact to the valve, wherein the reseal member permits fluidflow when coupled to the valve and restricts fluid flow when uncoupledfrom the valve.
 11. The apparatus of claim 11, further comprising asecond valve at a location remote from the isolation enclosure, thesecond valve capable of removably associating in fluid flow contact tothe adaptor.
 12. The apparatus of claim 1, wherein the extraction memberis a piercing pin.
 13. An adaptor for fluidly connecting to a valve,comprising: a body having an elongated fluid passage therethrough; afastening element located at a proximal end of the body for releasablycoupling the adaptor to the valve; an actuating post located at aproximal end of the body and along the fluid passage, adapted topenetrate the valve and open the valve to fluid flow when the adaptor iscoupled to the valve; and a reseal member coupled to the actuating postto permit fluid flow through the adaptor when the adaptor is coupled tothe valve and restrict fluid flow through the adaptor when the adaptoris uncoupled from the valve.
 14. The apparatus of claim 13, wherein thereseal member has a preslit opening that is normally closed due to theresiliency of the reseal member.
 15. The apparatus of claim 14, whereinthe preslit opening is adapted to receive a hollow spiked pin of thevalve, opening the adaptor to fluid flow from the valve through thevalve hollow spiked pin.
 16. The apparatus of claim 13, furthercomprising a port located at a distal end of the body and along thefluid passage, adapted to fluidly connect the adaptor to a needlelesssyringe.
 17. A latching extraction element for use with a sealed vial,comprising: a body portion having an elongated fluid passagetherethrough; a connecting member located at a distal end of the bodyportion in fluid communication with the fluid passage; a extractionmember located at a proximal end of the body portion in fluidcommunication with the fluid passage, adapted to enter the vial and toremove material from the vial through the fluid channel; a primaryengaging member mounted on the body portion, adapted to secure the vialto the extraction member in a primary fixed position wherein theextraction member extends into the vial for removal of materialtherefrom; and a preceding engaging member mounted on the body portion,adapted to secure the vial in a preceding fixed position adjacent to theextraction member such that the extraction member is located outside thevial.
 18. The apparatus of claim 17, wherein the primary engaging memberhas a plurality of latch arms equally spaced peripherally around thebody portion and extending from the body portion in the same directionas the extraction member.
 19. The apparatus of claim 18, wherein thepreceding engaging member has a pair of latch arms equally spacedperipherally around the body portion and extending from the body portionin the same direction as the extraction member.
 20. The apparatus ofclaim 19, wherein the latch arms of the primary engaging member are instaggered relation to the latch arms of the preceding engaging member onand around the body portion.
 21. The apparatus of claim 1, wherein theextraction member is a piercing pin.
 22. A method of accessing materialsfrom a sealed vial, comprising: placing the vial in an open impermeableisolation enclosure; closing the impermeable isolation enclosure;securing the vial to the impermeable isolation enclosure in a fixedposition; and selectively accessing the contents of the vial externallyfrom the impermeable isolation enclosure, while the vial remains in thefixed position.
 23. The method of claim 22, further comprising the stepof simultaneously piercing the vial and securing the vial to theimpermeable isolation enclosure.
 24. The method of claim 22, furthercomprising the step of simultaneously removing at least a portion of thecontents of the vial and maintaining the contents in isolation.
 25. Themethod of claim 24, further comprising the step of transferring theremoved portion of the contents while maintaining the contents inisolation.
 26. The method of claim 22, further comprising the step ofsecuring the vial to the impermeable isolation enclosure in a precedingfixed position prior to closing the impermeable isolation enclosure. 27.A method of accessing materials from a sealed vial, comprising: placingthe vial in an open impermeable isolation enclosure; closing theimpermeable isolation enclosure; piercing the vial while inside theimpermeable isolation enclosure; removing at least a portion of thecontents of the vial; and transferring the removed portion of thecontents and maintaining the contents in isolation, while the vialremains pierced.
 28. The method of claim 27, further comprising the stepof simultaneously securing the vial to the impermeable isolationenclosure in a fixed position while the vial is pierced.
 29. The methodof claim 27, further comprising the step of securing the vial to theimpermeable isolation enclosure in a preceding fixed position withoutpiercing the vial prior to closing the impermeable isolation enclosure.30. A method of accessing materials from a sealed vial, comprising:securing the vial to the impermeable isolation enclosure in a precedingfixed position; closing the impermeable isolation enclosure; andselectively accessing the contents of the vial externally from theimpermeable isolation enclosure.
 31. The method of claim 30, furthercomprising the step of simultaneously piercing the vial and securing thevial to the impermeable isolation enclosure in a primary fixed position,prior to accessing the contents of the vial.
 32. The method of claim 30,further comprising the steps of removing at least a portion of thecontents of the vial, transferring the removed portion while maintainingthe contents in isolation.
 33. The method of claim 30, furthercomprising the steps of simultaneously piercing the vial and securingthe vial to the impermeable isolation enclosure in a primary fixedposition, prior to accessing the contents of the vial; removing at leasta portion of the contents of the vial; and transferring the removedportion and maintaining the contents in isolation while the vial remainspierced and in the primary fixed position.